MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 01/28/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus and evaluation is pending and microbial testing.The scope will be sent to an independent laboratory for microbial testing.As part of our investigation, on (b)(4) 2019 an olympus endoscopy support specialist (ess) was dispatched to the user facility to observe the facility¿s reprocessing practices and provide training if necessary.Upon arrival the ess was informed that the facility did not have a leak tester and wanted the in-service/observation to be rescheduled for a later date.To date the user facility has not finalized date for this visit.If additional information received this report will be supplemented accordingly.

Event Description

Olympus was informed that two patients developed klebsiella pneumonia infections after undergoing cystoscopy procedures using two of the facility¿s cystonephrofiberscopes (sn.(b)(4), sn.(b)(4)).The patients were treated with intravenous antibiotics.In addition, the user facility reported that they use enzyme and aldahol cleaner to disinfect and clean the scope.The minimum effective concentration is being checked every 2 weeks.The endoscope channel is being brushed during manual cleaning using a reusable brush (model: unk).The scope is precleaned immediately after the procedure as it is rinsed, flushed, soaped and the steps are then repeated.The scope is not being leaked tested prior to manual cleaning.Air is flushed into the scope after reprocessing.There is no known issue with the facility¿s automatic endoscope reprocessor (aer) (model: unk).The facility's last in-service with an olympus endoscopy support specialist was conducted on (b)(4) 2019.There have been no changes to the facility¿s reprocessing staff since the last in-service.The user facility reported that all the reprocessing staffs were trained on how to properly reprocess an endoscope.This is 1 of 2 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the endoscopy support specialist (ess).The ess reported that several unsuccessful attempts were made to contact the customer to schedule an in-service.To date the customer has not responded to finalize a date.

Manufacturer Narrative

The scope was sent to an independent laboratory for microbial testing.The scope's instrument channel was cultured and no klebsiella organism or any other microbial growth was recovered from the scope.The scope was then ethylene oxide (eto) sterilized and returned to olympus for a device evaluation.Olympus performed a visual inspection on the scope using an olympus boroscope and a telescope which found discoloration on the wall of biopsy channel at the distal end opening, kink near the middle of channel, and slight brownish stain on the k-mount near the channel opening on the control body side.There was also chemical damage/dried residue noted on the light guide lens, bending section cover, bending section cover glue and insertion tube.The scope passed leak testing.Based on the evaluation findings, the kink within the channel is due to mishandling.The cause of the discoloration/chemical damage on the bending section cover, bending section cover glue, insertion tube, and biopsy channel (brownish stain) is due to improper reprocessing.The instruction manual provides the users several warnings to ¿after using this instrument, reprocess and store it according to the instructions given in the endoscope¿s companion reprocessing manual.Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.Do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector of the endoscope with excessive force.The endoscope may be damaged.¿.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8364743
• MDR Text Key: 136986410
• Report Number: 2951238-2019-00453
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170328817
• UDI-Public: 04953170328817
• Combination Product (y/n): N
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-5R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention